Three leaders in menopause innovation have been shortlisted for a Femtech World Award.

The Menopause Innovation of the Year award, sponsored by Cross-Border Impact Ventures (CBIV), recognises those showing exceptional innovation in addressing the health, wellbeing and quality-of-life needs of people navigating perimenopause, menopause, and beyond.

CBIV is an impact venture capital firm on a mission to revolutionise venture investing in health technology.

CBIV invests in early-growth stage health technology companies commercialising medical devices, diagnostics, therapeutics, and digital health innovations and leveraging cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML)

The Menopause Innovation of the Year award is one of 10 being celebrated at Femtech World’s third annual awards event.

The winner of this and all other awards will be revealed at a virtual event on June 19.

Congratulations to the shortlist and thank you to everyone who entered.

Menopause Innovation of the Year Shortlist

Noctera by Bonafide is a hormone-free, prescription-free, melatonin-free dietary supplement designed to combat sleep disruptions caused by hormonal changes – it’s been shown to improve quality of sleep, reduce sleep disturbances and increase daytime energy.

While other dietary supplements for sleep exist, products targeted at menopausal women focus more on managing night sweats because of their relationship to disrupted sleep. Noctera is a true menopausal sleep product targeting sleep disruptions caused by hormonal changes.

A randomized, double-blind, placebo-controlled trial demonstrated that Noctera significantly enhances sleep quality in perimenopausal and postmenopausal women who are experiencing moderate-to-severe sleep disturbances. 

Owning Your Menopause (OYM) was founded by Kate Rowe-Ham — personal trainer, bestselling author, and perimenopause survivor — with a single mission: to give midlife women expert-led fitness, nutrition, and wellbeing support that is designed specifically for them.

The result is a platform that members describe as feeling made for them. That is not an accident. It is the outcome of deep empathy, expert knowledge, and relentless commitment to a community that has historically been underserved by both the fitness industry and healthcare system.

OYM is not just an app. It is evidence that the right technology, in the right hands, can transform health outcomes for women who need it most.

The Womeno digital platform, Womeno App and Womeno-Friendly Workplaces programs combine holistic,science-driven, and deeply user-centered approach in addressing one of the most overlooked yet critical areas in women’s health.

One of the strongest reasons for this nomination is Womeno’s team commitment to practical, evidence-based solutions.

Rather than relying on trends or anecdotal wellness claims, Womeno integrates medical expertise, research-backed insights, and easy-to-use digital tools that empower every woman to make informed decisions about her health.

The FDA has delayed approval of camizestrant while it reviews new analyses submitted by AstraZeneca after advisers voted against the breast cancer drug.

The US regulator had been considering whether to approve the oral treatment after a phase 3 switching study in a specific group of breast cancer patients.

Camizestrant is an oral SERD, or selective oestrogen receptor degrader. These drugs are designed to block and break down oestrogen receptors that can help some breast cancers grow.

AstraZeneca filed for approval based on the phase 3 Serena-6 trial, which tested a treatment-switching approach.

Patients in the study received an aromatase inhibitor and a CDK4/6 inhibitor. Aromatase inhibitors lower oestrogen levels, while CDK4/6 inhibitors are targeted cancer drugs that help slow cancer cell growth.

After detecting an ESR1 mutation, investigators switched the aromatase inhibitor to camizestrant.

An ESR1 mutation is a change in a gene linked to the oestrogen receptor. It can make some breast cancers less responsive to standard hormone treatments.

AstraZeneca said switching to camizestrant was linked to a 56 per cent increase in progression-free survival.

Progression-free survival measures how long a patient lives without their disease getting worse.

However, the FDA raised questions about the study design.

An FDA advisory committee later voted six to three that AstraZeneca had failed to show camizestrant provides a clinically meaningful benefit.

The vote was a setback for the company’s hopes of approval, although the FDA can go against advisory committee recommendations.

After the setback, AstraZeneca submitted additional analyses requested by the FDA.

The company said the analyses include data on circulating tumour DNA clearance linked to longer-term efficacy outcomes.

Circulating tumour DNA refers to fragments of genetic material from cancer cells that can be found in the blood.

AstraZeneca is expected to share the data next week at the American Society of Clinical Oncology annual meeting.

The FDA has now delayed its ruling while it reviews the additional information. AstraZeneca did not provide a new decision date.

Three-month delays are typical and, during the second Trump administration, have been common.

After budget cuts reduced its workforce, the FDA delayed rulings on assets including Bayer’s Lynkuet, Biohaven’s troriluzole and Sanofi’s tolebrutinib. The FDA reportedly blamed a “heavy workload and limited resources” for one delay.

The agency has continued to delay rulings this year, with Biogen, Savara and Travere Therapeutics among the companies to say the FDA has extended reviews of their drugs.

Like AstraZeneca, those three companies faced delays after submitting additional information that the agency needed time to review.

If the additional analyses address the regulator’s concerns, AstraZeneca could still secure approval for a drug it has estimated could generate peak sales of more than US$5bn.

Guggenheim Securities analysts recently described the Serena-6 study as “a limited commercial opportunity in our and [AstraZeneca’s] view”.

AstraZeneca is also running two adjuvant studies and a trial in a first-line setting as it seeks to position camizestrant across different stages of breast cancer care.

Adjuvant treatment is given after primary treatment, such as surgery, to reduce the risk of cancer returning. First-line treatment is the first therapy given for a disease.

Roche reported the failure of its rival oral SERD in first-line breast cancer in March, but AstraZeneca executives have argued that their trial designs and drug candidate are different.

Last week, Europe’s Committee for Medicinal Products for Human Use issued a positive opinion on camizestrant.

The drug is expected to be marketed as Etcamah in Europe.

In this episode of the FemTech World Podcast, host Stephanie Price speaks with Dr Malissa Wood, Chief Medical Officer at Women As One, about the gender gap in cardiology and what it means for patient care.

Women as One is on a mission to build infrastructure, not just raise awareness, to ensure women receive accurate, equitable cardiovascular care worldwide.

Stephanie and Malissa discuss:

• Why women remain underrepresented in cardiology leadership and research
• How structural barriers, visibility, and network access limit women’s careers
• How diverse research teams improve cardiovascular outcomes for women
• The power of mentorship and sponsorship in retaining women in cardiology
• Future milestones for gender equity, from clinical trials to medical education

Listen now on YouTube or your podcast platform of choice: